Intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature. This guide wire may also be used to cross or assist in crossing de novo chronic total coronary occlusions (CTO).

Device Description

The HI-TOROUE PROGRESS Guide Wire (K091825, cleared Sept. 25, 2009) is an existing family of guide wires, designed to provide improved torque response and crossing while maintaining tactile feedback in stenotic vessels. The subject wire is a core to tip design, where the core material runs through the entire length of the wire. This family of guide wires has a maximum diameter of 0.0140" with a stainless steel core and is provided in 190cm extendable and 300cm exchange lengths. The distal core segment of the PROGRESS guide wire family is offered in 5 configurations: PROGRESS 40. PROGRESS 80, PROGRESS 120, PROGRESS 140T and PROGRESS 200T. Each configuration is identical in design except for those design features that impact tip stiffness.

The HI-TOROUE PILOT Guide Wire (K030549/K101116, originally cleared Mav 14, 2003) is an existing family of guide wires constructed using a 304V stainless steel core. HI-TORQUE PILOT Guide Wires have a maximum diameter of 0.0140" and are available in 190cm extendable lengths and a 300 cm exchange length. There are three HI-TORQUE PILOT™ Guide Wire designs with varying tip stiffness (i.e., HI-TORQUE PILOT™ 50, HI-TORQUE PILOT™ 150, and HI-TOROUE PILOT™ 200 Guide Wires). The distal segment of the guide wire includes a series of tapered grinds and a flat section, which reduce the diameter and stiffness of the distal core, thus yielding the desired flexibility and performance.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance Study

The study, named "EXPERT CTO Guidewire Clinical Trial," was a prospective, multi-center, single-arm study designed to assess the safety and effectiveness of the HI-TORQUE (HT) PROGRESS and HT PILOT guide wires in recanalization of chronic total occlusions (CTO).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Goal)	Reported Device Performance (Primary Endpoint)	Lower Bound of One-Sided 95% CI	P-value
62.5%	79.0% (109/138 successful recanalizations)	72.8%	<0.0001

Breakdown of individual criteria for successful recanalization:

Individual Criteria	Reported Performance (All Guidewires)	Reported Performance (Study Guidewires only, Alternate Analysis)
Confirmation of placement of any guide wire in the distal true lumen	89.9% (124/138)	N/A (this metric was for any guide wire, not just study wires)
Absence of in-hospital MACE** (ARC MI definition)	89.1% (123/138)	N/A
Confirmation of placement of the study guide wire in the distal true lumen	N/A	60.1% (83/138)
Absence of in-hospital MACE** (per protocol MI definition)	97.8% (135/138) (Alternate Analysis)	97.8% (135/138)

Note: The primary endpoint focused on successful recanalization using any guide wire (which included the study guidewires), achieving a lower one-sided 95% CI above the 62.5% performance goal. An alternate analysis using a different MACE definition also confirmed the success, and a separate analysis for study guidewires only for specific components (like successful placement and MACE) was performed but not for the overall primary endpoint.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for the Test Set: 138 subjects were enrolled for the guidewire portion of the study.
Data Provenance: The study was a "prospective, multi-center, single-arm study." The text does not specify the country of origin, but generally, multi-center studies for US regulatory submissions typically involve sites in the US and potentially other regions. The study is prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not explicitly state the "number of experts" used to establish ground truth for the test set. However, it describes a clinical trial where "Successful guide wire crossing was defined as confirmation of the presence of a guide wire in the distal true lumen." This confirmation would typically be performed by interventional cardiologists involved in the procedures and potentially reviewed by an independent clinical events committee (though not explicitly stated for this specific detail).

The text mentions the study objectives for the EXPERT CTO clinical trial: "assess the safety and effectiveness of the HI-TORQUE (HT) PROGRESS and HT. PILOT guide wires in recanalization of chronic total occlusions". The "successful recanalization" and "absence of in-hospital MACE" (Major Adverse Cardiac Events) are clinical outcomes reported.

Given the nature of the trial, the ground truth for success (e.g., successful guide wire crossing, absence of MACE) would have been established by the treating physicians (interventional cardiologists) and possibly an independent clinical events committee, as is standard for clinical trials. The qualifications of these experts would be based on their medical licensure and experience in interventional cardiology.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method like 2+1 or 3+1. For clinical trials involving endpoints like MACE, an independent Clinical Events Committee (CEC) is typically used to adjudicate events to ensure consistency and minimize bias. However, this specific detail is not provided in the summary. The endpoints (successful guide wire crossing, absence of MACE) are clinical observations made during or after the procedure.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on the device's performance directly in patients, not on how human readers (e.g., radiologists interpreting images) improve with or without AI assistance. The device in question is a guide wire, which is a physical tool used in interventional procedures, not an AI diagnostic software.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a physical medical device (guide wire), not an algorithm or AI software. Therefore, the concept of "standalone" performance for an algorithm does not apply. The study evaluates the performance of the physical guide wire when used by a human physician in a clinical setting.

7. The Type of Ground Truth Used

The ground truth used is clinical outcomes data from a prospective human clinical trial.

Successful recanalization of the CTO: Defined by two components:
- Confirmation of placement of any guide wire in the distal true lumen.
- Absence of in-hospital MACE (Major Adverse Cardiac Events).
Confirmation of guide wire in distal true lumen: This would be assessed by the interventional cardiologist during the procedure, likely using angiography.
Absence of in-hospital MACE: MACE events (e.g., MI, death, stroke) are serious clinical outcomes, typically recorded from hospital records and often adjudicated by an independent CEC in clinical trials. The study uses both ARC MI definition and per protocol MI definition for MACE.

8. The Sample Size for the Training Set

Not applicable. This study describes a clinical trial evaluating a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The 138 subjects are part of the test set for evaluating the device's clinical performance.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, this is a clinical trial for a physical device, so there is no training set for an AI algorithm.

Summary

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510(k) Summary - K123067

Abbott Vascular Inc.

The 510(k) Summary is submitted in accordance with 21 CFR §807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990.

1. Submitter's Name
1. Submitter's Address
1. Telephone
1. Fax

1. Contact Person
1. Date Prepared
1. Device Trade Name(s)

(951) 914-3031

(951) 914-0339

Sean Mullin

Sept 28, 2012

Guide Wire

Hi-Torque Progress Guide Wire Family

P.O. Box 9018, Temecula, CA 92589

Hi-Torque Pilot Guide Wire Family

Catheter Guide Wire (DQX)

Device Common Name
Device Classification Name
Predicate Device(s) Name(s)

HI-TORQUE PROGRESS Guide Wire (K091825, cleared Sept. 25, 2009)

HI-TORQUE PILOT Guide Wire (K030549/K101116, originally cleared May14, 2003)

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7.1 Device Description (HI-TOROUE PROGRESS)

7.2 Device Description (HI-TOROUE PILOT)

7.3 Indication for Use (HI-TOROUE PROGRESS and HI-TOROUE PILOT)

Intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may be used to reach and cross a target lesion. provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature. This guide wire may also be used to cross or assist in crossing de novo chronic total coronary occlusions (CTO).

7.4 Technological Characteristics

There have been no physical changes to the subject devices as compared to the currently marketed predicate devices except for a change in indication and related clinical information provided in the IFU and labeling. Comparisons of the technological characteristics such as product performance, design, and intended use between the subject and predicate devices show that they are substantially equivalent.

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7.5 In Vitro Bench, Biocompatibility, Packaging and Sterilization Testing

There have been no physical changes to the subject devices as compared to the predicate devices except for a change in indication statement and related clinical information provided in the IFU and labeling. Comparisons of in-vitro bench, biocompatibility, packaging, and sterilization testing are not necessary. The subject and predicate devices are identical and in-vitro bench testing, biocompatibility, packaging and sterilization for the subject devices are therefore substantially equivalent to their respective predicate devices.

7.6 EXPERT CTO Guidewire Clinical Trial Summary

Objectives

The primary objectives of this trial are to:

assess the safety and effectiveness of the HI-TORQUE (HT) PROGRESS and HT . PILOT guide wires in recanalization of chronic total occlusions and
assess the safety and effectiveness of the MINI TREK Coronary Dilatation . Catheter in predilatation of chronic total occlusions.
assess the safety and effectiveness of the XIENCE V, XIENCE nano, and . XIENCE PRIME Everolimus Eluting Coronary Stent Systems for the treatment of chronic total coronary occlusions.

Although the guidewire and predilatation portions of the EXPERT CTO clinical trial are complete, the longer term safety and effectiveness results of the XIENCE V and XIENCE PRIME stent systems in the treatment of chronic total occlusions is ongoine. The MINI TREK predilatation results and XIENCE V and XIENCE PRIME results will be reported separately.

Trial Design

The EXPERT CTO is a prospective, multi-center, single-arm study. Approximately 250 subjects with signs and/or symptoms considered typical of ischemic heart disease attributed to a CTO are expected to be enrolled. Subjects will undergo elective, attempted CTO percutaneous revascularization.

For the initial 138 subjects enrolled. HT PROGRESS or HT PILOT guide wires (the study guidwires) were used in each case. Other, non-study guidewires may also have been used in each case at the discretion of the physician. Successful guide wire crossing was defined as confirmation of the presence of a guide wire in the distal true lumen. Guide wire subjects were followed through hospital discharge. The target lesions were predilated using a standard angioplasty balloon. For at least the initial 60 subjects with successful guide wire crossing, identified as confirmation of the guide wire in the distal true lumen, the MINI TREK Coronary Dilatation Catheter was to be used for the first predilatation attempt. The XIENCE V and/or XIENCE PRIME stents were to be used in all subjects

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for whom recanalization and predilatation of the target lesion was completed. Stent subjects are to be followed through 5 years with follow-up at 30 days, 6 months, 1 year, and annually thereafter through 5-years.

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7.7 -Results

Primary Endpoint Analysis

The primary endpoint of successful recanalization of the CTO was achieved in 79.0% (109/138) of the subjects with a lower one-sided 95% confidence interval (CI) of 72.8%. The individual criteria for successful recanalization included: confirmation of placement of any guide wire in the distal true lumen in 89.9% (124/138) of the subjects and absence of in-hospital MACE (per ARC MI definition) in 89.1% (123/138) of the subjects.

Because the lower one-sided 95% Cl is above the protocol-specified performance goal of 62.5% (p<0.0001), the study guide wire is considered to have successfully met its endpoint. Refer to Table 7-2

	Guide WireSuccess	Two-sided95% CI	PerformanceGoal	LowerBound ofone-sided95% CI	P-value
Guide Wire-related Endpoint	79.0% (109/138)	[71.2%,85.5%]	62.50%	72.8%	<0.0001
Confirmation of placement of anyguide wire in the distal true lumen	89.9% (124/138)	[83.6%,94.3%]	--	--	--
Absence of in-hospital MACE**	89.1% (123/138)	[82.7%,93.8%]	--	--	--

Table 7-2 Primary Endpoint Results – All Guidewires

** Based on ARC MI.

To allow for a more meaningful comparison to literature, an alternate analysis of the primary endpoint was performed. The successful recanalization rate was calculated using the MI per protocol definition for the second component of absence of in-hospital MACE. , Successful recanalization of the CTO was achieved in 87.7% (121/138) of the subjects with a lower one-sided 95% CI of 82.3%. Table 7-3 shows the results of the alternate analysis of the primary endpoint. The individual criteria for successful recanalization included: confirmation of placement of the guide wire in the distal true lumen in 89.9% (124/138) of the subjects and absence of in-hospital MACE (per protocol MI definition) in 97.8% (135/138) of the subjects. The lower bound of the one-sided 95% CI of the primary endpoint in the secondary analysis is approximately 20% above the protocolspecified performance goal of 62.5% (p<0.0001).

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Table 7-3 Alternate Analysis of the Primary Endpoint

	Guide WireSuccess	Two-sided95% CI	PerformanceGoal	Lower Boundof one-sided95% CI	P-value
Guide wire-relatedEndpoint	87.7%(121/138)	[81.0%,92.7%]	62.50%	82.3%	<.0001
Confirmation ofplacement of anyguide wire in thedistal true lumen	89.9%(124/138)	[83.6%,94.3%]	--	--	--
Absence of in-hospital MACE**	97.8%(135/138)	[93.8%,99.5%]	--	--	--

(MACE Includes Per Protocol Definition of MI)

** Based on per protocol MI

Table 7-4 shows the results for the alternate analysis for the study guidewires only.

Table 7-4 Alternate Analysis of the Primary Endpoint Results

(Confined to Study Guide-Wires, MACE Includes Per protocol Definition of MI)

	Guide Wire Success	Two-sided 95% CI
Guide wire-related Endpoint	58.0% (80/138)	[49.3%,66.3%]
Confirmation of placement of the studyguide wire in the distal true lumen	60.1% (83/138)	[51.5%,68.4%]
Absence of in-hospital MACE**	97.8% (135/138)	[93.8%,99.5%]

7.8 Clinical Summary Conclusion

The EXPERT CTO clinical trial and results demonstrate that the study guide wires, HI-TORQUE PROGRESS and HI-TORQUE PILOT families, were successfully used to treat chronic total coronary occlusions and that the primary and secondary endpoints of the guide wire portion of the study were met, and therefore support a CTO indication for these wires. No new safety or effectiveness issues were raised during the testing program and, therefore, these devices may be considered substantially equivalent to the predicate devices.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

JAN 2 9 2013

Abbott Vascular, Inc. C/O Mr. Sean Mullin 26531 Ynez Road Temecula, CA 92589

Re: K123067

Trade/Device Name: Hi-Torque Progress Guide Wire Family and Hi-Torque Pilot Guide Wire Family

Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: December 14, 2012 Received: December 17, 2012

Dear Mr. Mullin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Matthew G. Hillebrenner

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number(s) (if known): _K123067

Device Name(s):

Hi-Torque Progress Guide Wire Family Hi-Torque Pilot Guide Wire Family

Indications for Use:

Prescription Use : X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

11/23067 510(k) Number

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.